The guidelines section keeps you up to date with respect to the current published guidelines of the pharmaceutical industry.
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Q3 ICH Guidelines for Impurities: Q3A (R2): Impurities in New Drug Substances: First recommended for adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step …
Q3 ICH Guidelines for Impurities Read More »
Q2 Analytical Validation: The guideline Q2 analytical validation identifies validation parameters that are needed for various analytical methods. Here are two revisions of the Q2 analytical validation guideline; Q2(R1): Validation …
ICH Guideline: Q2 Analytical Validation Read More »
ICH stability Guidelines Q1A to Q1F: This Guidelines have been developed by the appropriate ICH Expert Working Group and have been subject to consultation by the regulatory parties, in accordance …
ICH stability Guidelines Q1A – Q1F Read More »
Before understanding the purpose for the revision of stability ICH guidelines need to understand what ICH stands for. What is ICH Full form? ICH stands for “International Council for Harmonization …
Q1A (R2) Stability ICH guideline purpose of revision Read More »
Clinical Trials In Human Medicines as per EU: For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results of clinical trials carried out …
Clinical Trials In Human Medicines as per EU Read More »
In this article, we are going to learn about Scope of ICH Q10 and Objective of ICH Q10 in pharmaceutical. ICH Q10 In Pharmaceutical Quality System In 2008, ICH Q10 …
What is ICH Q10 in the Pharmaceutical Quality System? Read More »
As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 title of electronic code of …
50 Electronic Codes of Federal Regulation (e-CFR) in pharma Read More »
21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized systems that used to store …
Important Difference between 21 CFR part 11 and EU Annex 11 Read More »
